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OpenTrials
Completed

NCT Number: NCT01446848

Oral Iron Supplementation in Pulmonary Hypertension

The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

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Key information

Conditions

Pulmonary Arterial Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Iron Deficiencies Iron Metabolism Disorders Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Respiratory Tract Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 21 and older
  • diagnosis of idiopathic pulmonary arterial hypertension
  • iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)

Exclusion criteria

  • active infection, malignancy, or bleeding
  • hemochromatosis
  • chronic inflammatory or autoimmune disease
  • currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
  • allergy to iron

Treatment and study plan

Iron Supplement

Dietary Supplement

325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.

Other names: ferrous sulfate tablets

Primary outcomes

  1. Change in Zinc protoporphyrin from baseline

    Time frame: 3 months

  2. Change in serum ferritin from baseline

    Time frame: 3 months

Secondary outcomes

  1. Change in serum erythropoietin from baseline

    Time frame: 3 months

  2. Change in transferrin saturation from baseline

    Time frame: 3 months

  3. Change in %CD34+/133+ cells from baseline

    Time frame: 3 months

  4. Change in pulmonary arterial pressure from baseline

    Time frame: 3 months

    estimated using echocardiogram

  5. Change in six minute walk distance from baseline

    Time frame: 3 months

  6. NYHA/WHO classification

    Time frame: 3 months

  7. Side effects of iron supplementation

    Time frame: 3 months

  8. Deaths and hospitalizations greater than 24 hours

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2011
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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